The present invention relates to heart valve replacement and repair devices such as collapsible prosthetic heart valves. More particularly, the present invention relates to devices and methods for using prosthetic heart devices having diagnostic capabilities.
Diseased or damaged native heart valves may be repaired or replaced using prosthetic devices. In some instances, devices, such as annuloplasty rings, are used to repair and restore the function of a malfunctioning native heart valve. If repair is not possible, the function of native heart valves may be replaced by prosthetic devices, such as tissue valves (i.e., surgical valves). Such a replacement typically requires an open-heart surgical procedure.
In addition to these devices, prosthetic heart valves that are collapsible to a relatively small circumferential size can be delivered into a patient less invasively than surgical valves. For example, a collapsible valve may be delivered into a patient via a tube-like delivery apparatus such as a catheter, a trocar, a laparoscopic instrument, or the like. This collapsibility can avoid the need for more invasive procedures such as full open-chest, open-heart surgery.
Collapsible prosthetic heart valves typically take the form of a valve structure mounted on a stent. There are two types of stents on which the valve structures are ordinarily mounted: a self-expanding stent and a balloon-expandable stent. To place such valves into a delivery apparatus and ultimately into a patient, the valve must first be collapsed or crimped to reduce its circumferential size.
When a collapsed prosthetic valve has reached the desired implant site in the patient (e.g., at or near the annulus of the patient's heart valve that is to be replaced by the prosthetic valve), the prosthetic valve can be deployed or released from the delivery apparatus and re-expanded to full operating size. For balloon-expandable valves, this generally involves releasing the entire valve, and then expanding a balloon positioned within the valve stent. For self-expanding valves, on the other hand, the stent automatically expands as the sheath covering the valve is withdrawn.
It would be advantageous to monitor the function of prosthetic devices, including annuloplasty rings, surgical valves and transcatheter valves, before, during and after implantation to ensure proper function for short-term and long-term assessment. For example, calcification of the aortic valve may affect the performance and anchoring of transcatheter implants. Calcification may also be associated with leakage, such as paravalvular leakage around the exterior of a medical device or aortic regurgitation through the interior of a medical device.
There therefore is a need for improvements in the devices, systems, and methods for monitoring prosthetic heart devices before, during and after implantation. Specifically, there is a need for improvements in the devices, systems, and methods for accurately measuring parameters associated with proper prosthetic heart valve functionality. Among other advantages, the present disclosure may address one or more of these needs.